Out of Specification (OOS) Test Results

 Out of Specification (OOS) Test Results

OOS (Out of Specification)

The failure of  a batch or any of its components to meet any of its specifications

OOS indicates non-compliance with specifications

Outliers

Statistically invalid individual test result

Can be eliminated

OOS – General Principles

How should we handle OOS results?

OOS cannot be ignored or discounted without basis

When does testing stop (accept the result)

  • First test failure?
  • Second test failure? Tenth test failure?
cGMP Part 211.192
The failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated…
The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure of discrepancy…
cGMP Part 211.194
A written record of the investigation shall include the conclusions and follow-up…
A complete record of all data secured in the course of each test…
Complete records shall be maintained of all stability testing performed…
for details infarmation please download the fallowing PPT….

Out of Specification (OOS) Test Results PPT

Leave a Comment